The Hemobahn endoprosthesis: a self-expanding polytetrafluoroethylene-covered endoprosthesis for the treatment of peripheral arterial occlusive disease after balloon angioplasty.

Abstract

Endoluminal management of occlusive arterial disease has previously been limited to balloon angioplasty, either alone or with stent placement. This article discusses the Hemobahn endoprosthesis, a polytetraflouroethylene-covered nitinol stent graft. The Hemobahn device design characteristics, Food and Drug Administration phase I feasibility trial design and results, phase II pivotal trial design, and single-site phase II trial results are reviewed. The long-term outcomes of patients treated with angioplasty and Hemobahn stent grafting will determine the role of stent grafting in the management of occlusive arterial lesions below the aortic bifurcation.